First-in-human, phase I trial of PM14 in advanced solid tumors
Research type
Research Study
Full title
Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumours
IRAS ID
1003897
Contact name
Luis Mora Capitán
Contact email
Sponsor organisation
Pharma Mar, S.A.
Eudract number
2017-001118-27
Clinicaltrials.gov Identifier
Research summary
Despite recent progress in the treatment of solid tumors, advanced and metastatic cancer remains without a cure. There is an urgent need for the development of new therapeutic options, particularly those with new mechanisms of action. PM14 is an experimental anticancer drug that has shown to kill cancer cells in several animal studies. This study will be the first time PM14 is being tested in humans. It will evaluate whether the positive effect observed on cancer cells in animals is also present in humans. PM14 has not been approved by the European Competent Authority or other Regulatory Authorities. Pharma Mar, S.A. and Pharma Mar USA, Inc. are the Sponsor of this clinical trial in which medical centers in France, Spain, US and UK will participate. The study will be divided in two stages. The main purpose of the first stage is to test the safety of PM14, at different dose levels and to find out the effects, good or bad, that PM14 has on different types of cancer. Small groups of people are receiving a due dose of PM14 that, if well tolerated, is increased in the next small group. This will continue until the highest safe dose that can be given without causing serious or unmanageable side effects is found. Once this dose has been found, the second stage will include a larger group of patients with the main purpose of learning more about the effects of PM14 on some specific types of cancer. The secondary purpose of this study is to determine how PM14 is distributed and eliminated from the body, and to determine if more information can be obtained about how it works against cancer and interacts with the body. A complete cycle of treatment will last 21 days. PM14 will be administered as an intravenous infusion on Days 1 and 8, or only on Day 1 of each 21-day cycle. Patients will be randomly assigned to one of these schedules. PM14 will be administered as long as the disease is effectively controlled and treatment is well tolerated.
REC name
London - Central Research Ethics Committee
REC reference
22/LO/0522
Date of REC Opinion
12 Aug 2022
REC opinion
Further Information Unfavourable Opinion